The real unmet need: A multifactorial approach for identifying sensitized kidney candidates with low access to transplant.

BACKGROUND: At the start of 2020, the kidney waiting list consisted of 2526 candidates with a calculated panel reactive antibody (CPRA) of 99.9% or greater, a cohort demonstrated in published research to have meaningfully lower than average access to transplantation even under the revised kidney allocation system (KAS). METHODS: This was a retrospective analysis of US kidney registrations using data from the OPTN [Reference (https://optn.transplant.hrsa.gov/data/about-data/)]. The period-prevalent study cohort consisted of US kidney-alone registrations who waited at least 1 day between April 1, 2016, when HLA DQ-Alpha and DP-Beta unacceptable antigen data became available in OPTN data collection, to December 31, 2019. Poisson rate regression was used to model deceased donor kidney transplant rates per active year waiting and using an offset term to account for differential at-risk periods. Median time to transplant was estimated for each IRR group using the Kaplan-Meier method. Sensitivity analyses were included to address geographic variation in supply-to-demand ratios and differences in dialysis time or waiting time. RESULTS: In this study, we found 1597 additional sensitized (CPRA 50-<99.9%) candidates with meaningfully lower than average access to transplant when simultaneously taking into account CPRA and other factors. In combination with CPRA, candidate blood type, Estimated Post-Transplant Survival Score (EPTS), and presence of other antibody specificities beyond those in the current, 5-locus CPRA were found to influence the likelihood of transplant. CONCLUSION: In total, this suggests approximately 4100 sensitized candidates are on the waiting list who represent a community of disadvantaged patients who may benefit from progressive therapies and interventions to facilitate incompatible transplantation. Though associated with higher risks, such interventions may nevertheless be more attractive than remaining on dialysis with the associated accumulation of mortality risk over time.

Transplant recipients are vulnerable to coverage denial under Medicare Part D.

Transplant immunosuppressants are often used off-label because of insufficient randomized prospective trial data to achieve organ-specific US Food and Drug Administration (FDA) approval. Transplant recipients who rely on Medicare Part D for immunosuppressant drug coverage are vulnerable to coverage denial for off-label prescriptions, unless use is supported by Centers for Medicare & Medicaid Services (CMS)-approved compendia. An integrated dataset including national transplant registry data and 3 years of dispensed pharmacy records was used to identify the prevalence of immunosuppression use that is both off-label and not supported by CMS-approved compendia. Numbers of potentially vulnerable transplant recipients were identified. Off-label and off-compendia immunosuppression regimens are frequently prescribed (3-year mean: lung 66.5%, intestine 34.2%, pancreas 33.4%, heart 21.8%, liver 16.5%, kidney 0%). The annual retail cost of these at-risk medications exceeds $30 million. This population-based study of transplant immunosuppressants vulnerable to claim denials under Medicare Part D coverage demonstrates a substantial gap between clinical practice, current FDA approval processes, and policy mandates for pharmaceutical coverage. This coverage barrier reduces access to life-saving medications for patients without alternative resources and may increase the risk of graft loss and death from medication nonadherence.

Barriers to vaccination in renal transplant recipients.

Vaccine-preventable diseases remain at the forefront of challenges in the long-term care of renal transplant recipients (RTR). Although global vaccination campaigns targeting patients with end-stage renal disease or RTR are standard, rates of vaccination among renal transplant candidates and RTRs remain suboptimal. We highlight the multifactorial barriers leading to low vaccination rates in this vulnerable population.

Assessing pharmacologic and nonpharmacologic risks in candidates for kidney transplantation.

PURPOSE: Pharmacotherapy concerns and other factors with a bearing on patient selection for kidney transplantation are discussed. SUMMARY: The process of selecting appropriate candidates for kidney transplantation involves multidisciplinary assessment to evaluate a patient's mental, social, physical, financial, and medical readiness for successful surgery and good posttransplantation outcomes. Transplantation pharmacists can play important roles in the recognition and stratification of pharmacologic and nonpharmacologic risks in prospective kidney transplant recipients and the identification of issues that require a mitigation strategy. Key pharmacotherapy-related issues and considerations during the risk assessment process include (1) anticoagulation concerns, (2) cytochrome P-450 isoenzyme-mediated drug interactions, (3) mental health-related medication use, (4) chronic pain-related medication use, (5) medication allergies, (6) use of hormonal contraception and replacement therapy, (7) prior or current use of immunosuppressants, (8) issues with drug absorption, (9) alcohol use, (10) tobacco use, (11) active use of illicit substances, and (12) use of herbal supplements. Important areas of nonpharmacologic risk include vaccine delivery, infection prophylaxis and treatment, and socially related factors such as nonadherent behavior, communication barriers, and financial, insurance, or transportation challenges that can compromise posttransplantation outcomes. CONCLUSION: Consensus opinions of practitioners in transplantation pharmacy regarding the pharmacologic and nonpharmacologic factors that should be considered in assessing candidates for kidney transplantation are presented.

Changing transplant recipient education and inpatient transplant pharmacy practices: a single-center perspective.

PURPOSE: Pharmacists' contributions to improved inpatient medication practices and educational services for kidney transplant recipients at a community hospital were evaluated. SUMMARY: A retrospective observational analysis was conducted using demographic and case data collected during the year before (2007) and three years after (2011) the inclusion of pharmacists on the hospital's interdisciplinary kidney transplant team. Qualitative variables assessed included changes in prescribing practices, inpatient and outpatient transplant personnel, discharge planning processes, medication reconciliation, educational practices, and transplant program workflow; quantitative variables included average hospital length of stay (LOS), Scientific Registry of Transplant Recipients data, readmission rates, and reimbursement data. A comparison of data on kidney transplant procedures performed at the hospital in 2007 (n = 60) and 2011 (n = 54) indicated that the implementation of specialized transplant pharmacy services was particularly beneficial in the areas of inpatient medication management, medication reconciliation, discharge planning, and patient education. Program outcomes related to the inclusion of pharmacists on the kidney transplant team included a decrease in the mean LOS among transplant recipients (from 7.8 days in 2007 to 3.4 days in 2011, p < 0.001), with no adverse effect on all-cause 30-, 90-, and >90-day readmission rates (all p > 0.09). Annual cost savings attributable to the reduction in LOS were estimated at $279,180. CONCLUSION: The participation of pharmacists on the kidney transplant team enhanced a hospital's medication management, discharge planning, and patient education services for transplant recipients, helping to reduce their average LOS and yielding substantial cost savings.

Billing for outpatient transplant pharmacy services.

PURPOSE: The economic impact of out-patient pharmacy services in a transplant program was evaluated. METHODS: Full-time kidney transplant pharmacy services were implemented at Providence Sacred Heart Medical Center (PSHMC) in the fall of 2008, with two pharmacists combining hours to provide one full-time-equivalent position. At PSHMC, posttransplantation patients are seen three times per week. The number of patient visits with pharmacists for 2010 was compared with the total number of patient visits. The face-to-face time spent with the patient was translated to a level of billing that was associated with a set reimbursement schedule. For each patient encounter in which a pharmacist was involved, the incremental difference between the nursing and pharmacy levels of billing was examined, as were the levels most often billed by pharmacists. The difference in billing levels between pharmacists and nurses for the same patient encounter was also evaluated. RESULTS: Overall, pharmacist visits accounted for 208 (22%) of the 994 out-patient kidney transplant visits in 2010, with pharmacists billing at a higher level of acuity compared with nursing for the same patient encounter 48% of the time. This translated to an approximate increase of $100 per patient visit. For the one-year study period, pharmacists utilizing facility- fee billing increased out-patient reimbursement by approximately $10,000. CONCLUSION: By utilizing outpatient facility-fee billing for pharmacy services, the transplant program at PSHMC increased reimbursement in the outpatient setting.